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Study of Alemtuzumab to Treat Advanced Mycosis Fungoides/Sezary Syndrome

Primary Purpose

Mycosis Fungoides, Sezary Syndrome

Status

Unknown status

Phase

Phase 2

Locations

Peru

Study Type

Interventional

Intervention

alemtuzumab

About this trial

This is an interventional treatment trial for Mycosis Fungoides focused on measuring Alemtuzumab, Mycosis fungoides, Sezary

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Above 18 years old Eastern Cooperative Oncology Group (ECOG) 0-2 Liver and renal function test less than twice upper label No active infection Written informed consent One to three regimens of previous chemotherapies Exclusion Criteria: Abnormal renal or hepatic function Mycosis fungoides/Sezary syndrome in transformation HIV + HTLV-1 + Pregnancy Lactation

Sites / Locations

Schering Peruana S.A.Recruiting

Outcomes

Primary Outcome Measures

Overall response

Time to relapse

Event free survival

Secondary Outcome Measures

Toxicity

Full Information

NCT ID

NCT00157274

First Posted

September 7, 2005

Last Updated

April 2, 2007

Sponsor

Latin American Cooperative Onco-Haematology Group - Peru

1. Study Identification

Unique Protocol Identification Number

NCT00157274

Brief Title

Study of Alemtuzumab to Treat Advanced Mycosis Fungoides/Sezary Syndrome

Official Title

Phase II Study of Alemtuzumab in Patients With Advanced Mycosis Fungoides/Sezary Syndrome

Study Type

Interventional

2. Study Status

Record Verification Date

September 2005

Overall Recruitment Status

Unknown status

Study Start Date

July 2005 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

July 2008 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Latin American Cooperative Onco-Haematology Group - Peru

4. Oversight

5. Study Description

Brief Summary

The investigators designed a compassionate basis phase II study for refractory/relapsed mycosis fungoides/Sezary syndrome consisting of alemtuzumab (Campath) for primary evaluation of overall response and time to relapse. Other goals to consider are toxicity and time to new therapy.

Detailed Description

20 relapsed or refractory advanced mycosis fungoides/Sezary syndrome patients are scheduled with gradually escalated doses (3 mg, 10 mg , and 30 mg) on sequential days during the first week, followed by 30 mg three times a week until 12 weeks. Patients must have serology negative for human T-lymphotropic virus 1 (HTLV-1) and until three different regimens of chemotherapy. Follow up for one year after last cycle of alemtuzumab.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Mycosis Fungoides, Sezary Syndrome

Keywords

Alemtuzumab, Mycosis fungoides, Sezary

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

20 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

alemtuzumab

Primary Outcome Measure Information:

Title

Overall response

Title

Time to relapse

Title

Event free survival

Secondary Outcome Measure Information:

Title

Toxicity

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Julia M Huamani, MD

Phone

511-2227020

juliahuamaniz@yahoo.es

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Brady E Beltran, MD

Organizational Affiliation

LACOGH - PERU

Official's Role

Principal Investigator

Facility Information:

Facility Name

Schering Peruana S.A.

City

Lima

ZIP/Postal Code

511

Country

Peru

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jesus A Arones, MD

Phone

99480078

alfredo_arones@hotmail.com

12. IPD Sharing Statement

Citations:

PubMed Identifier

12543862

Citation

Lundin J, Hagberg H, Repp R, Cavallin-Stahl E, Freden S, Juliusson G, Rosenblad E, Tjonnfjord G, Wiklund T, Osterborg A. Phase 2 study of alemtuzumab (anti-CD52 monoclonal antibody) in patients with advanced mycosis fungoides/Sezary syndrome. Blood. 2003 Jun 1;101(11):4267-72. doi: 10.1182/blood-2002-09-2802. Epub 2003 Jan 23.

Results Reference

result

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Study of Alemtuzumab to Treat Advanced Mycosis Fungoides/Sezary Syndrome

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